Mortality and 30-day readmission rate following leadless pacemaker implantation: insights from the Nationwide Readmissions Database

Abstract

Abstract Background Clinical trials and registry data showed encouraging outcomes for leadless pacemaker (LP) implantation. However, reports of patient characteristics, trends, and clinical outcomes in a real-world population are limited. Purpose To provide real-world evidence of the rates, trends, and patient characteristics associated with in-hospital complications and 30-days readmission after LP implantations. Methods Using the all-payer, nationally representative Nationwide Readmissions Database between 2017 and 2019, we analyzed leadless or conventional pacemaker implantations. The national trends of in-hospital mortality, in-hospital complication rates and 30-day readmission rates after pacemaker implantation and their national trends were analyzed. Mixed-effects multivariable logistic regression analysis was performed to identify factors associated with in-hospital death and 30-days readmission in LP patients. Results A total of 137,732 admissions (age: 78 [70–85], 5,986 LP implantations) were analyzed (Figure 1). The in-hospital mortality, overall in-hospital complication rate, and 30-days readmission rates after LP implantations were 5.0%, 16%, and 16%, respectively. In LP recipients, the national estimate of in-hospital mortality declined from 10.9% in the second quarter of 2017 to 4.3% in the fourth quarter of 2019 (P<0.001) (Figure 2a). Furthermore, the national estimate of overall complication rate declined from 20.6% in the second quarter of 2017 to 13.0% in the fourth quarter of 2019 (P<0.001) (Figure 2b). Conversely, non-elective 30-day readmission rate did not show any increasing or decreasing trends in LP recipients (P=0.74) (Figure 2c). In LP recipients, female sex (odds ratio [OR] 1.42, 95% confidence interval [CI] 1.04–1.93), history of heart failure (OR 2.02, 95% CI 1.46–2.79), and first quartile annual pacemaker implantation hospital volume (OR 2.49, 95% CI 1.56–3.97, fourth quartile annual pacemaker implantation hospital volume used as a reference standard) were factors associated with in-hospital death. Conclusions Analysis of the nationally representative claims database in the US showed in-hospital mortality, complication rates, and non-elective 30-day readmission rate of 5.0%, 16%, and 16% respectively, for LP implantation performed during hospitalization. Although in-hospital mortality and complication rates showed a decreasing trend over time, ongoing surveillance is needed for the safety of LP implantation. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Intramural research fund (21-6-9)for cardiovascular diseases of national cerebral and cardiovascular center.